Aurobindo Pharmaceutical Limited – FDA Warning Letter, Aug 12, 2021

The FDA inspected Aurobindo Pharmaceutical Limited Unit I, FEI 3004021253, in Telangana, India, from August 2-12, 2021, and found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), rendering their API adulterated.

Key violations include: 1. **Failure to evaluate changes' effect on quality:** The firm increased an acceptable impurity limit in an API starting material without fully evaluating the impact on API quality. This involved an inadequate lab-scale study that relied on an unapproved manufacturing step and an analytical method not validated for new impurities. The firm's retrospective studies were deemed insufficient as they were not completed before the change. 2. **Inadequate quality unit investigation of critical deviations:** The firm failed to fully investigate discrepancies, specifically during a GC-MS method transfer where a failing result was invalidated without scientific rationale and proper reporting. The attributed root cause (deteriorated column) lacked established controls for future prevention, and the appropriateness of the analytical method was not considered.

These deviations are repeat observations from a July 29, 2019, regulatory meeting, indicating inadequate executive management oversight. The FDA strongly recommends engaging a qualified CGMP consultant.

Required corrective actions include a comprehensive, independent assessment of the change management system and the overall deviation investigation system, including a retrospective review of invalidated OOS results for US products over the last three